Aastrom Biosciences has initiated patient enrolment in the Revive Phase 3 clinical trial, designed to evaluate the efficacy and safety of Ixmyelocel-T in the treatment of patients with critical limb ischemia (CLI).
The randomised double-blind placebo-controlled multicentre Revive phase 3 trial will enroll 594 CLI patients who have no option for revascularisation and also have existing tissue loss due to ischemia, at 80 sites in the US.
In the study, patients will be followed for a total of 18 months, including 12 months from randomisation for efficacy and an additional six months for safety.
The primary endpoint of the Revive trial includes amputation-free survival at 12 months.
Aastrom Biosciences president and chief executive officer Tim Mayleben said the Revive Phase 3 trial is intended to advance Ixmyelocel-T through the final phase of clinical development and regulatory review.
"We are all very excited about the potential to rapidly bring this important new therapy through development to benefit the hundreds of thousands of CLI patients who have no other good treatment options available," Mayleben added.
University of Colorado professor of medicine and CPC Clinical Research president William Hiatt said the initiation of the study is the result of interactions with the FDA in a Special Protocol Assessment (SPA) review process designed to ensure the integrity of both the cellular therapy product and the clinical trial to evaluate the therapy in a critically ill patient population.
The study is being supported by an independent steering committee of renowned leaders in vascular medicine and clinical research who will provide independent oversight as well as medical and clinical guidance.
The US Food and Drug Administration (FDA) has granted fast track designation for the Revive clinical trial, the firm said.
The company has advanced Ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical programme to study patients with critical limb ischemia and a planned Phase 2b clinical trial in patients with ischemic dilated cardiomyopathy.
Aastrom Biosciences develops patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases using its cell-processing technology.